Quality Assurance
Quality Assurance
No concessions when it comes to the integrity of your clinical trial.
Quality transparency and accountability are the cornerstone of our success, and of yours.
Rigorous regulatory scrutiny is necessary and benefits everyone: patients, sponsors, regulators and clinical trial service providers.
Our worldwide network of laboratories and dedicated GxP Pharma sites are committed to continuously maintaining, interrogating and improving our Quality Management System in order to exceed quality standards and ensure the irreproachability of your clinical trial.
You may need study-specific support in one or more of the below-listed GCP areas:
- Audits of investigational site
- Third party vendors (laboratories, product manufactures etc.)
- Trial Master File
- Database
- Statistics
- Study reports
Accreditations and certifications and quality documents
Eurofins’ entities place high priority on Quality Assurance and Quality Control as stated in its Mission Statement and Corporate Values.
Our Global Quality System is designed to encompass all relevant aspects of both international and country-specific quality standards and regulatory guidelines.
Quality is evaluated by the appropriate national and international Accreditation Bodies via accreditation and certification, as well as other audits including a peer review by Eurofins own staff.
Eurofins Optimed owns a solid data-driven track record of successful audits by regional, national and international regulatory bodies and clients
Download our quality documents
- Compliance with Good Clinical Practice (GCP). Inspection by the French Medicines Agency (ANSM)
- Auvergne Rhône Alpes Regional Medicines Agency (ARS)
- Eurofins Optimed’s Quality Assurance manual
- Eurofins Optimed’s list of Standard Operationg Procedures (SOPs)
- Eurofin Optimed’s organisational chart
